10 Technique to pass the Requlatory Affairs Certification

1. Regulatory Affairs Certification (RAC) Global Scope Exam Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

2. Regulatory Affairs Certification (RAC) What is RAC Regulatory Affairs Certification (RAC) An individual certification for our global industry. Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

3. What can Regulatory Affairs do for Your Business? “I see regulatory affairs as a strategic advantage for the business because it's an extremely complex subject. It's complex in terms of the data requirements to satisfy all the regulatory authorities, but it's also very, very complicated in terms of the number of product classifications. The companies which understand all the data requirements and all the complexities which exist are the companies that win in the long run.” - Kenneth James, senior vice president, Research & DevelopmentConsumer Healthcare, GSK

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5. RAC (US): Knowledge of US regulations. Accredited by the National Commission for Certifying Agencies (NCCA). RAC (EU): Knowledge of European Union regulations. RAC (CAN): Knowledge of Canadian regulations. RAC (Global): Knowledge and critical thinking skills related to the international practice of regulatory affairs, with special attention paid to global standards from ICH, GHTF (through IMDRF), WHO and ISO.

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8. Question No 1: Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A. Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B. Validation of systems to ensure accuracy C. Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D. Establishment of and adherence to written procedures Answer: A Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

9. Question No 2: Notice of Intent to Revoke license can be issued for the following reason, EXCEPT? A. Unable to gain access to the manufacturing plant, B. Licensed product are no longer safe and effective C. Failure to report serious adverse event, D. Manufacturer fails to conform to applicable standards Answer: C Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

10. Question No 3: The following biological products are regulated by CBER EXCEPT? A. Immunizing toxoids, B. Monoclonal antibodies for in vitro use, C. Monoclonal antibodies for in vivo use, D. Infusion of animal sourced cells into a hum Answer: B Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

11. Question No 4: If a device failure is occurring with greater than expected frequency and investigation of the problem indicates improper use by the end user, which of the following should occurs? A. The labeling is revised, B. The product is recalled, C. The product is redesigned, D. A Dear Doctor letter is issued Answer: A Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

12. Question No 5: Question No 5: Which of the following statements is TRUE for Phase 2 clinical investigations of a previously untested drug? A. They are designed to determine the metabolic and pharmacokinetic effects B. They are intended to gather additional info C. They are conducted to determine the common short-term side effects and risks associated with the drug D. They are performed to provide an adequate bioavailability of the drug Answer: C Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

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